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It has been shown, that in patients with very severe chronic obstructive pulmonary disease (COPD) the additional use of non-invasive ventilation during pulmonary rehabilitation (PR) may enhance the benefits of PR. It is assumed that the non-invasive ventilation techniques provides a better recovery of the respiratory pump during the night. If non-invasive ventilation also decreases the metabolic demands during night is unknown and is aim of this study. During a 3 week inpatient pulmonary rehabilitation program a total of 85 patients with chronic obstructive pulmonary disease stage IV will be recruited for this study. There will be a 4:1 distribution into 2 groups. 68 patients with an indication for the use of a non-invasive ventilation will be involved in the intervention group where non-invasive ventilation will be initialized. 17 patients with chronic obstructive pulmonary disease stage IV without an indication for the use of non-invasive ventilation will be involved in a control group to detect the changes in nocturnal energy expenditure produced by pulmonary rehabilitation alone. All outcome measurements will be performed during day 1-3 and will be repeated after 12 days (with or without non-invasive ventilation) at day 15-17 of the pulmonary rehabilitation program.
A sub-trial of this study is to validate night movement accuracy of the Dynaport activity monitor with the observations made by a night-vision camera in the sleep lab. This will be performed in study participants as well as in healthy volunteers.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| nocturnal non-invasive ventilation | Active Comparator | patients will undergo 12 nights of non-invasive ventilation during pulmonary rehabilitation |
|
| no nocturnal non-invasive ventilation | No Intervention | patients will undergo pulmonary rehabilitation without nocturnal non-invasive ventilation |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| nocturnal non-invasive ventilation | Device | patients will undergo a non-invasive ventilation during the night |
|
| Measure | Description | Time Frame |
|---|---|---|
| energy expenditure during night | energy expenditure will be assessed by Sensewear Armband | day 1-3 and day 14-16 |
| Measure | Description | Time Frame |
|---|---|---|
| energy expenditure during day | energy expenditure will be assessed by SenseWear Armband | day 1-3 and day 14-16 |
| lung function | measured by a bodyplethysmograph |
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Inclusion Criteria for Intervention group:
Exclusion Criteria for Intervention group:
Inclusion Criteria for control group:
Exclusion Criteria for control group:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Klaus Kenn, Dr. | Contact | +49 8652 931451 | kkenn@schoen-kliniken.de | |
| Rainer Gloeckl | Contact | +49 8652 931630 | rgloeckl@schoen-kliniken.de |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Schoen Klinik Berchtesgadener Land | Recruiting | Schönau am Königssee | Bavaria | 83471 | Germany |
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| day 1-3 and day 14-16 |
| sleep quality | measured by Severe Respiratory Insufficiency Questionnaire | day 1-3 and day 14-16 |
| arterial pressure of carbon dioxide during night | measured transcutaneously by a Sentec device | day 1-3 and day 14-16 |
| movement activity during the night | night movement activity will be measured in a subgroup with the Dynaport device | day 1 |
| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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